The U.S. Court of Appeals for the D.C. Circuit last Friday largely upheld the Federal Trade Commission’s (“FTC”) ruling that POM Wonderful, Inc. violated the Federal Trade Commission Act by making unwarranted disease-prevention claims for its pomegranate juice products. But the ruling is far from the sweeping endorsement of FTC advertising-control measures that the Commission might have been hoping for. In particular, the ruling provides little, if any, support for the FTC’s recent assertions that food and dietary supplement manufacturers are largely barred from including health-related claims on product labels unless their claims are supported by randomized and controlled human clinical trials (“RCTs”). To the contrary, the appeals court made clear medical studies that do not meet RCT standards may nonetheless have considerable value, and that the FTC’s regulation of advertising is subject to strict First Amendment limitations. The decision suggests that courts may be very reluctant to uphold the FTC’s application of RCT standards to claims that a product promotes general health and nutrition, as distinct from claims that a product is effective in preventing or curing specific diseases.
POM’s ads were an easy target for the FTC. The ads touted POM’s products as effective in preventing a variety of diseases/conditions, including cardiovascular disease, prostate cancer, and erectile dysfunction (“ED”). Yet they failed to mention numerous shortcomings in the medical studies on which the disease-prevention claims were based—including that the studies’ findings were directly contradicted by other, larger clinical studies. Indeed, the D.C. Circuit held that it would have concluded that the ads were deceptive even had it chosen to apply a de novo standard of review to the FTC’s findings. (Because the case was on appeal from an FTC administrative proceeding, the D.C. Circuit reviewed those findings under a far more deferential “substantial evidence” standard.) Continue reading